Evaluation of the Prevalence of Asthma in a Cohort of Children Born After In Vitro Fertilization (Aged 11-15) Compared With Spontaneously Conceived Children of the Same Age Range
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,792
- 试验地点
- 1
- 主要终点
- Prevalence of asthma
研究概览
简要总结
Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of fertility decline likely caused by changes in both environment and social behaviour. Considering this large usage, it is important to evaluate the potential risk on the health of children conceived using ART.
According to the literature, children born after ART are more likely to be at higher risk of health problems than spontaneously conceived ones. Interestingly, recent studies suggested an increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).
The purpose of this study is to evaluate the prevalence of asthma in school adolescents from a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to a control group composed of the same age range spontaneously conceived individuals.
The expected outcome of this study will provide new information regarding these children to ART professionals of and to their own families, by focusing on an age range (between 11 and 15 years) for which very little information is available to date.
详细描述
The methodology is a comparative epidemiological survey, between children from a historical cohort born after intraconjugal In Vitro Fertilization (singleton or twin) aged 11-15 years and a control group recruited in schools after the agreement of Academic Inspection.
Parents of the two groups will be contacted either by phone calls or through written information given in the schools. They will receive the questionnaire and an information letter, once they give their agreement to be a part of the study.
Data collection will be conducted using two anonymous questionnaires. The first questionnaire was built based on items proposed in the international Health Behaviour in School-aged Children (HBSC) survey of the World Health Organization (WHO). The second questionnaire will be sent to parents. It will focus on the pregnancy and it will be used to adjust the analysis.
This study was submitted and approved by an Institutional Review Board in France (Comité de Protection des Personnes Sud-Méditerranée II) on 11th September 2015.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children conceived by Intraconjugal In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment
- •Children aged 11-15 years
- •Singleton and twins
- •School children
- •Control :
- •Children born spontaneously (without IVF)
- •Children aged 11-15 years
- •Children in the same place of schooling of the case
排除标准
- •Children not born by Intraconjugal In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment (donor)
- •Children whose parents refuse the participation
- •Triplet and more pregnancies
- •Children who cannot attend ordinary school
- •Children from families where an infant has passed away
- •When the participation agreement was not signed
- •Control :
- •Children whose parents have benefited ART
- •When the participation agreement was not signed
- •Children whose aged and sex are unknown
- •Triplet and more pregnancies
结局指标
主要结局
Prevalence of asthma
时间窗: 15 month
(will be assessed using the questionnaire of international Health Behaviour in School-aged Children \[HBSC\] survey).
次要结局
- Age of puberty in girls(15 month)
- Prevalence of chronic diseases other than asthma(15 month)
- Physical well-being(15 month)
- Anthropometric measures(15 month)
研究者
Pierre Boyer
Head of Assisted Reproductive Technologies Laboratory
Hospital St. Joseph, Marseille, France